Suit Therapy

Number: 0696

Table Of Contents

Policy
Applicable CPT / HCPCS / ICD-10 Codes
Background
References

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Policy

Scope of Policy

This Clinical Policy Bulletin addresses the suit therapy device, the Dynamic Lycra Suit, the Dynamic Movement Orthosis, and the Benik Dynamic Trunk Orthosis.

1. Experimental and Investigational

   Aetna considers the following interventions experimental and investigational because the effectiveness of these approaches has not been established:

   1. Suit therapy or home use of a suit therapy device (also known as the Adeli Suit, elastomeric tissue dynamic orthosis, Penguin Suit, Polish Suit, Stabilizing Pressure Input Orthoses, Therapy Suit, Therasuit, and TheraTogs) for the treatment of members with cerebral palsy (CP) or other conditions (e.g., gait rehabilitation following stroke);
   2. Dynamic movement TLSO "brace" (Dynamic Lycra Suit) for the treatment of members with CP or scoliosis;
   3. Dynamic Movement Orthoses for the treatment of members with CP, hemiparesis/hemiplegia, scoliosis, and all other indications;
   4. Thoracic lumbar sacral orthosis (TLSO) for the treatment of autism;
   5. The Benik vest/trunk support (Benik dynamic trunk orthosis) for individuals with low trunk tone and all other indications. 

2. Related Policies

   • CPB 0405 - Mechanical Stretching Devices for Contracture and Joint Stiffness

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Table:

CPT Codes / HCPCS Codes / ICD-10 Codes

Code	Code Description
Information in the [brackets] below has been added for clarification purposes.   Codes requiring a 7th character are represented by "+":
CPT codes not covered for indications listed in the CPB:
There is no specific code for suit therapy:
HCPCS codes not covered for indications listed in the CPB:
Suit therapy device, Dynamic Movement Orthoses, Benik vest/trunk support (Benik dynamic trunk orthosis) - no specific code:
L1200	Thoracic-lumbar-sacral-orthosis (tlso), inclusive of furnishing initial orthosis only
ICD-10 codes not covered for indications listed in the CPB (not all-inclusive):
F84.0 - F84.9	Pervasive developmental disorders
G80.0 - G80.9	Cerebral palsy
G81.00 - G81.94	Hemiplegia and hemiparesis
I69.00 - I69.998	Sequelae of cerebrovascular disease
M40.00 - M41.9	Kyphosis and scolliosis
M62.81 - M62.89	Other specified disorders of muscle [low trunk tone]

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Background

The Adeli Suit (also known as the Polish Suit, Therapy Suit, and Therasuit) is a modification of a space suit, called the “Penguin” suit used by Russian cosmonauts to counter the effects of long-term weightlessness on the body while in space.  The inner workings of the suit have elastic bands and pulleys that created artificial force against which the body could work to help prevent muscle atrophy and osteoporosis.

Although the cause of motor dysfunction between cerebral palsy (CP) patients and astronauts are different, results of a treatment trial with the Penguin suit to rehabilitate patients with CP appeared promising.  The Penguin suit was then modified resulting in an elasticized suit for use in positioning and stretching muscles during physical therapy.  Suit therapy for CP is currently available at the Euromed Clinic in Poland and at several other centers in Europe and the United States.  The Adeli Suit is used in the Polish facility as part of a comprehensive program of intensive physiotherapy administered 5 to 7 hours per day for 5 to 6 days a week for 4 weeks.

According to the Euromed Rehabilitation Center website: "The Adeli Suit consists of a vest, shorts, knee pads and specially adapted shoes with hooks and elastic cords that help tell the body how it is supposed to move in space.  Therapists use the Adeli Suit to hold the body in proper physical alignment.  During specialized exercises, the therapists adjust the elastic connectors that topographically mirror flexor and extensor muscles, trunk rotators and the lower limbs.  Additional attachments correcting the position of the feet, head and other areas of the body have also been designed.  A patient, while wearing the Adeli Suit, goes through various exercises including "how to walk".  The Suit works as an elastic frame surrounding the body and does not limit the amplitude of movement but adds an additional weight load on it within designed limits."

There are published anecdotal reports (the majority of which are published in the Russian language) of children gaining in speech, fine motor control, as well as movement with suit therapy, but no randomized controlled clinical trials of suit therapy have been published.  The U.S. Food and Drug Administration (FDA) has classified the Adeli Suit and other similar devices as a class 1 limb orthosis (brace).  Thus, the Adeli Suit is exempt from the premarket notification procedures of the FDA and the manufacturer is not required to provide evidence of efficacy prior to marketing. 

Enough interest has been generated by anecdotal and verbal reports that the United Cerebral Palsy (UCP) Research and Educational Foundation (2004) funded 2 studies on suit therapy.  While the results of these studies are not yet available in the peer-reviewed published medical literature, the UCP Research and Educational Foundation website is making the information available due to the current interest in suit therapy. 

The first study by Dr. Alexander Frank and associates at the Motion Analysis Laboratory, Assaf Harofeh Medical Center, Zerifin, Israel, reported the results of 24 children who had CP and a functional level of II, III or IV according to the Gross Motor Function Classification System.  Patients were randomly assigned to either a standard physical therapy program or to the Adeli Suit.  Both groups were treated 5 days per week for 2 hours.  Marginal improvement was noted in both groups without any statistical difference in results between the 2 groups.

A second study by Dr. Edward Dabrowski at the Children's Hospital of Michigan reported the results of 57 children, all of whom received 1 hour of physical, occupational, and speech therapy 3 times a week for 8 to 10 weeks followed by a 4-week home program.  The experimental group wore the Adeli Suit for the last 4 weeks of their therapy program.  Both groups improved and sustained their improvement without any statistical difference in results between the 2 groups.  The UCP Foundation concluded that "[t]hese studies show that a period of intensive therapy in ambulatory children with cerebral palsy can lead to improvement in a number of disabilities.  However, they did not demonstrate that use of the Adeli Suit was helpful.  Any effect is likely to be minor."

Controlled clinical studies are necessary to determine the beneficial effects of suit therapy, if any, for the treatment of CP, especially which patients would benefit the most and how long any beneficial results would last.

Liptak (2005) reviewed 9 treatment modalities used for children who have CP including the Adeli Suit.  The author noted that no conclusive evidence either in support of or against the use of the Adeli suit is available.

Bar-Haim and colleagues (2006) compared the effectiveness of Adeli suit treatment (AST) with neurodevelopmental treatment (NDT) in children with CP.  A total of 24 children with CP, levels II to IV according to the Gross Motor Function Classification System (GMFCS), were matched by age and functional status and randomly assigned to the AST or NDT treatment groups.  In the AST group (n = 12; 8 males, 4 females; mean age of 8.3 years [SD 2.0]), 6 children had spastic/ataxic diplegia, 1 triplegia and 5 spastic/mixed quadriplegia.  In the NDT group (n = 12; 9 males, 3 females; mean age of 8.1 years [SD 2.2]), 5 children had spastic diplegia and 7 had spastic/mixed quadriplegia.  Both groups were treated for 4 weeks (2 hours daily, 5 days per week, 20 sessions).  To compare treatments, the Gross Motor Function Measure (GMFM-66) and the mechanical efficiency index (EIHB) during stair-climbing were measured at baseline, immediately after 1 month of treatment, and 10 months after baseline.  The small but significant time effects for GMFM-66 and EIHB that were noted after 1 month of both intensive physiotherapy courses were greater than expected from natural maturation of children with CP at this age.  Improvements in motor skills and their retention 9 months after treatment were not significantly different between the 2 treatment modes.  Post-hoc analysis indicated a greater increase in EIHB after 1 month (p = 0.16) and 10 months (p = 0.004) in AST than that in NDT, predominantly in the children with higher motor function (GMFCS Levels II and III).  The results suggested that AST might improve mechanical efficiency without a corresponding gain in gross motor skills, especially in children with higher levels of motor function.  These investigators also stated that "[f]uture studies on the effectiveness of AST should measure changes in metabolic efficiency and fitness level, as well as motor skills.  It is also important to determine changes induced by the suit itself, by having two groups perform the same physical training, with and without the suit.  Future studies should increase the number of participants and homogenize the participants with CP to reduce variability …. ".

TheraTogs (TheraTogs, Inc., Telluride, CO) are an orthotic undergarment that consist of a 2-piece body suit and a strapping system that is customized for the child.  TheraTogs are worn every day and, according to the manufacturer's website, are indicated for children with a variety of disorders, including ataxia, athetosis, low muscle tone, poor postural alignment and joint deviations.  There is a lack of evidence of the effectiveness of TheraTogs in the peer-reviewed, published medical literature.

Stabilizing Pressure Input Orthoses (SPIO) are made from a Lycra-like blend material that are intended to provide deep pressure through compression to improve positional limb and body awareness, core muscle and joint stabilization, and increase precision of muscle activation and movement.

Hylton and Allen (1997) stated that the use of flexible compression bracing in persons with neuromotor deficits offers improved possibilities for stability and movement control without severely limiting joint movement options.  This treatment modality has been explored with increasing application in children with moderate to severe CP and other neuromotor deficits with good success.  Significant functional improvements using Neoprene shoulder/trunk/hip bracing led these researchers to experiment with much lighter compression materials.  The stabilizing pressure input orthosis (SPIO) bracing system is custom-fitted to the stability, movement control and sensory deficit needs of a specific individual.  The SPIO bracing system supposedly can provide an improved base of support for functional gains in balance, dynamic stability, general and specific movement control with improved postural and muscle readiness.  However, there is currently insufficient evidence to support the effectiveness of SPIO.

Available evidence does not demonstrate durable benefits from the use of suit therapy for CP (NHSC, 2002; NHS QIS, 2005).

In a case report, Bailes et al (2010) investigated the effects of intensive suit therapy on gait, functional skills, care-giver assistance, and gross motor ability in children with CP.  Two children with spastic diplegia classified at level III on the GMFCS participated.  Outcomes were assessed using dimensions D and E of the GMFCS, the Pediatric Evaluation of Disability Inventory (PEDI), and instrumented gait analysis.  Each child participated in the Therasuit Method, 4 hours a day, 5 days a week for 3 weeks.  Very small improvements in function were noted in dimension D of the GMFCS and PEDI Self-care Domain with decreased function in other areas.  Improved walking speed, cadence, symmetry, joint motion, and posture were found with gait analysis.  The authors concluded that further investigation is needed of the suit itself, and intensive therapy programs in children with CP.

Bailes et al (2011) examined the effects of suit wear during an intensive therapy program on motor function among children with CP.  A total of 20 children were randomized to an experimental (TheraSuit) or a control (control suit) group and participated in an intensive therapy program.  The PEDI and GMFM-66 were administered before and after (4 and 9 weeks).  Parent satisfaction was also assessed.  No significant differences were found between groups.  Significant within-group differences were found for the control group on the GMFM-66 and for the experimental group on the GMFM-66, PEDI Functional Skills Self-care, PEDI Caregiver Assistance Self-care, and PEDI Functional Skills Mobility.  No adverse events were reported.  The authors concluded that children wearing the TheraSuit during an intensive therapy program did not demonstrate improved motor function compared with those wearing a control suit during the same program.

Maguire et al (2012) presented the protocol of a study designed to investigate the long-term effects on the recovery of gait, balance and social participation of gait rehabilitation with TheraTogs compared to gait rehabilitation with a cane following first time acute stroke.  This study will be a multi-center, single-blind, randomized trial with 120 patients after first stroke.  When subjects have reached Functional Ambulation Category 3 they will be randomly allocated into TheraTogs or cane group.  TheraTogs will be applied to support hip extensor and abductor musculature according to a standardized procedure.  Cane-walking held at the level of the radial styloid of the sound wrist.  Subjects will walk throughout the day with only the assigned walking aid.  Standard therapy treatments and usual care will remain unchanged and documented.  The intervention will continue for 5 weeks or until patients have reached Functional Ambulation category 5.  Outcome measures will be assessed the day before begin of intervention, the day after completion, 3 months, 6 months and 2 years.  Primary outcome is Timed "up and go" test; secondary outcomes are peak surface electromyography of gluteus maximus and gluteus medius, activation patterns of hemiplegic leg musculature, temporo-spatial gait parameters, hemiplegic hip kinematics in the frontal and sagittal planes, dynamic balance, daily activity measured by accelerometry, Stroke Impact Scale.  Significance levels will be 5 % with 95 % confidence intervals.  Intentio-t-treat analyses will be performed.  Descriptive statistics will be presented.  The authors concluded that this study could have significant implications for the clinical practice of gait rehabilitation after stroke, particularly the effect and appropriate use of walking aids.  The results could be important for the development of clinical guidelines and for the socio-economic costs of post-stroke care.

In a case-study, Matthews and Crawford (2006) noted that treatment of scoliosis has been under discussion in relation to surgical intervention since the Boston brace was presented by Hall in 1976.  The effects of rigid bracing on thoracic skeletal integrity and the possible deformation of ribs due to the high localized pressure due to prolonged wear have been high-lighted.  The lack of compliance has encouraged clinicians to examine other options for non-surgical treatment.  The Spinecor and Triac bracing systems have been developed as a result of this research; however, both of these orthoses had been designed with idiopathic scoliosis in mind.  Little research has been done into the effects of bracing on the neuropathic curve.  The use of dynamic Lycra garments in the treatment of neurological scoliosis offers the advantage of deformity correction without the bulk and discomfort of rigid braces.  Recent clinical experience has shown that the Lycra suits have a positive effect in the treatment of scoliosis.  The authors discussed the treatment of a child presenting with a spinal tumor and although not truly of neurological presentation indicates that the garment can be used for the different scoliotic presentations.

In a phase 1 exploratory study, Matthews et al (2009) aimed to establish proof of concept of the effects of dynamic elastomeric fabric orthoses (DEFOs) on the gait of children with spastic diplegic CP.  Replicated single case experiments employing an ABA methodology were carried out on 8 subjects (median age of 5.5 years, range of 3 to 13 years; 4 girls and 4 boys) utilizing quantitative/qualitative data collection.  Outcome measures were: 10-meter walking test (10MWT); physiological cost index (PCI); visual analog scale (VAS) scoring of perceived gait changes; functional mobility changes using Patient Specific Functional Scale (PSFS); subject/carer perceptions recorded in daily diaries.  Results identified following analysis of quantitative data indicated a treatment effect from the orthoses, which could be corroborated by participant's subjective impressions and comments.  Statistically significant (p < 0.05) intervention-related improvements in gait velocity and gait consistency were identified in 5/8 and 4/8 subjects, respectively.  Power calculations support the feasibility of a larger controlled study to further investigate this orthotic intervention.  This study indicated that DEFO leggings can confer beneficial effects on the gait of some children with spastic diplegia resulting from CP.  They noted that these findings have implications for orthotic intervention with this subject group.

In a pilot study, Jeon et al (2012) evaluated the feasibility of intensive training using a spring-assisted hand orthosis on upper extremity in individuals with chronic hemiparetic stroke.  A total of 5 participants for the experimental group and 5 for the control group were recruited from a local rehabilitation hospital.  Subjects in the experimental group participated in 4 weeks of training using a SaeboFlex orthosis for 1 hour per day, 5 times per week.  Each subject in the control group wore the same orthosis for 1 hour per day without participating in upper extremity training.  Outcome measures included the Fugl-Meyer Assessment, Box and Block Test, and Action Research Arm Test; kinematic parameters were collected using a 3-D motion analysis system.  The Fugl-Meyer assessment and the Box and Block Test score were increased significantly in the experimental group after the intervention.  The resultant velocity of the wrist joint for the reach-to-grasp task decreased significantly, and the resultant velocity of the shoulder joint while performing a reach-to-grasp task at acromion height decreased significantly in the experimental group.  The authors concluded that spring-assisted dynamic hand orthosis training is feasible in recovering the movement of the hemiparetic upper extremity.

In a pilot study, Barry et al (2012) compared the effect of therapy using a wrist-hand orthosis (WHO) versus manual-assisted therapy (MAT) for individuals with chronic, moderate-to-severe hemiparesis.  The relationship between the repetitions during therapy and functional change was also examined.  A total of 19 participants were randomly assigned to either the WHO group (n = 10) or the MAT group (n = 9).  The WHO group performed therapy while wearing a dynamic WHO (SaeboFlex), the MAT group performed therapy with manual assistance of a therapist.  Both groups participated in 1 hour of therapy per week for 6 weeks and were prescribed exercises to perform at home 4 days per week.  Pre- and post-training assessments included grip strength, the Action Research Arm Test (ARAT), Box and Blocks (B&B) test, and Stroke Impact Scale (SIS).  There were no significant between-group differences for any of the measures.  Within-group differences showed that the WHO group had a significant improvement in the ARAT score (mean = 2.2; p = 0.04).  The MAT group had a significant improvement on the percent recovery on the SIS (mean = 9.3 %; p = 0.03) and approached a significant improvement on the ARAT (mean = 1.4; p = 0.08).  When analyzing all participants together, the relationship between the number of exercise repetitions and functional improvement was moderate for the ARAT and the B&B test (r = 0.55, p = 0.02, and r = 0.30, p = 0.10, respectively).  The authors concluded that small improvements in function and perception of recovery were observed in both groups, with no definite advantage of the WHO. 

van der Heide and colleagues (2015) stated that numerous dynamic arm supports have been developed in recent decades to increase independence in the performance of activities of daily living.  Much effort and money have been spent on their development and prescription, yet insight into their effects and effectiveness is lacking.  These investigators performed a systematic review of evaluations of dynamic arm supports.  The 8 technical evaluations, 12 usability evaluations, and 27 outcome studies together make 47 evaluations.  Technical evaluations were often used as input for new developments and directed at balancing quality, forces and torques, and range of motion of prototypes.  Usability studies were mostly single-measure designs that had varying results as to whether devices were usable for potential users.  An increased ability to perform activities of daily living and user satisfaction were reported in outcome studies.  However, the use of dynamic arm supports in the home situation was reported to be low.  Gaining insight into why devices are not used when their developers believe them to be effective seems crucial for every new dynamic arm support developed.  The authors noted that the methodological quality of the outcome studies was often low, so it is important that this is improved in the future.

In a systematic review and meta-analysis, Martins and colleagues (2016) evaluated the effectiveness of suit therapy on functioning in children and adolescents with CP. These researchers performed a comprehensive search of peer-reviewed articles on electronic databases, from their inception to May 2014.  Studies included were rated for methodological quality using the Physiotherapy Evidence Database scale.  Effects of suit therapy on functioning were assessed using meta-analytic techniques.  From the 46 identified studies, 4 met the inclusion criteria and were included in the meta-analysis.  Small, pooled effect sizes were found for gross motor function at post-treatment (g = 0.46, 95 % confidence interval [CI]: 0.10 to 0.82) and follow-up (g = 0.47, 95 % CI: 0.03 to 0.90).  The authors concluded that the small number of studies, the variability between them, and the low sample sizes were limitations of this review.  Findings suggested that to weigh and balance benefits against harms, clinicians, patients, and families need better evidence to examine and prove the effects of short intensive treatment such as suit therapy on gross motor function in children and adolescents with CP.  Therefore, the authors stated that more research based on high-quality studies focusing on functioning in all dimensions of the International Classification of Functioning, Disability and Health perspective is needed to clarify the impact of suit therapy.

Almeida and colleagues (2017) noted that therapeutic suits or clothing, whether associated with intensive protocols or not, became popular in the rehabilitation of children with CP.  Studies have reported positive effects of these suits on children's posture, balance, motor function and gait.  A summary of current literature may help guide therapeutic actions.  These researchers evaluate the available evidence on the effects of interventions based on the use of therapeutic suits in the treatment of impairments and functional limitations of children with CP; 3 independent reviewers searched for experimental studies on Medline, SciELO, BIREME, LILACS, PEDro and CENTRAL databases, between October and December 2015 and updated in May 2016.  The reviewers evaluated the methodological quality of selected studies using the Checklist for Measuring Quality.  The Grading of Recommendations Assessment, Development and Evaluation was used to synthesize the quality of evidence and strength of recommendation.  From the 13 studies, 2 evaluated the Full Body Suit, 2 tested the Dynamic Elastomeric Fabric Orthose, 3 evaluated TheraTogs and 6 tested the TheraSuit/AdeliSuit protocols.  The quality of evidence for the Full Body Suit, the Dynamic Elastomeric Fabric Orthose and the TheraSuit/AdeliSuit protocols was very low for body structure and function outcomes, while the evidence for TheraTogs was low quality.  Regarding the activity outcomes, the Full Body Suit and TheraSuit showed very low quality evidence while the evidence for TheraSuit/AdeliSuit protocols were of low quality.  The authors concluded that enthusiasm with new therapeutic approaches that argue modifications in the neuro-musculoskeletal impairments and functional limitations of children with CP need to be guided by scientific evaluation.  They stated that the low quality of evidence suggested caution in recommending the use of these therapeutic suits.

Goyal and colleagues (2020) stated that Xia-Gibbs syndrome (XGS) is a recently discovered genetic disorder.  It is characterized by global developmental delay, intellectual impairment, hypotonia, and sleep abnormalities.  While the current literature emphasizes on the genotype and phenotype of this rare condition, it does not provide any description of the physiotherapy management of patients with XGS.  These researchers described the case of a 27-month old Indian male diagnosed with XGS, who presented with difficulty in sitting without support.  He had dysmorphic facies, hypotonia, hyper-extensible joints, mild kyphoscoliosis, and global developmental delay.  His parents and an elder female sibling were clinically asymptomatic.  The physiotherapy intervention was based on the principles of neurodevelopmental treatment (NDT) and sensory integration (SI).  The management included facilitation of transitions, weight-bearing exercises, wheel-barrow walking, joint compressions, rib cage mobilization, multi-directional reaching, and pushing-pulling activities along with the use of equipment like Swiss ball, balance board, stability disc, trampoline, swing system, walker (rollator), and walking harness.  Furthermore, SPIO for the trunk and ankle-foot orthosis (AFO) followed by supra-malleolar orthosis (SMO) were used for support.  Thereafter, the child was able to stand and walk without support at the age of 36 months; and walked on uneven terrain at the age of 42 months.  In addition, he could negotiate stairs using handrails with mild assistance.  His gross motor function measure-88 (GMFM-88) total score improved from 21 % at the presentation to 66.6 % following the treatment.  It was observed that the NDT and SI approaches along with the use of appropriate orthoses accelerated the achievement of motor milestones in this case.  The authors concluded that to the best of their knowledge, this was the 1st case report of a child with XGS that emphasized on the course of physiotherapy management for the associated motor delay.  Moreover, these researchers stated that further studies to examine the potential of physiotherapy in early intervention programs as well as during the life span of patients with XGS are needed.

El-Bagalaty and Ismaeel (2021) noted that osteoporosis because of physical inactivity is one of the major complications associated with neuromuscular disorders.  These researchers compared using Suit therapy and whole-body vibration (WBV) in addition to selected physical therapy (PT) program to improve bone mineral density (BMD) in children with CP of spastic diplegia.  A total of 46 patients were classified randomly into 2 equal groups.  Patients in group A engaged in a selected PT program in addition to suit therapy training program; while those in the group B received the same PT program as in group A in addition to the WBV training program.  The treatment programs were carried out 3 times/week for 12 successive weeks.  Measurements obtained included BMD at the lumbar spine as well as at the femoral neck; these measures were recorded pre- and post-treatment.  There was a significant improvement in favor of the WBV group; BMD improved significantly at both the lumbar spine (p = 0.038) and the femoral neck (p = 0.005) in the WBV group as compared to the Suit therapy group.  The authors concluded that WBV was effective in improving BMD rather than Suit therapy in children with CP of spastic diplegia.  They noted that this study was limited to one type of CP in addition to a limited range of age.  Moreover, these researchers stated that further future studies are needed on different types of CP, larger sample, for a longer period, using different age groups as well as using different assessment tools.

Dynamic Movement Orthoses

Serrao and colleagues (2017) noted that patients with cerebellar ataxia show increased upper body movements, which have an impact on balance and walking.  In a longitudinal, uncontrolled study, these researchers examined the effect of using dynamic movement orthoses (DMO), designed as elastic suits, on trunk motion and gait parameters.  A total of 11 patients (7 men, 4 women; mean age of 49.9 ± 9.5 years) with degenerative cerebellar ataxia were enrolled in this study.  Linear over-ground gait of patients was recorded using an opto-electronic gait analysis system before DMO use (DMO-) and during DMO use (DMO+).  Time-distance parameters, lower limb joint kinematics, body sway, trunk oscillations, and gait variability (coefficient of variation, CV) were recorded.  Patient satisfaction with DMO device was measured using Quebec user evaluation of satisfaction with assistive technology.  When using the DMO, patients showed a significant decrease in stance phase duration, double support phase duration, swing phase CV, pelvic range of movements (ROMs), body sway, and trunk ROMs.  A significant increase was observed in the swing phase duration and knee joint ROMs.  Of the 11 subjects, 10 were either quite satisfied (8 points) or very satisfied (2 points) with the assistive device.  The authors concluded that the DMO reduced the upper body motion and improved balance-related gait parameters.  These researchers proposed that DMO be used as an assistive/rehabilitative device in the neuro-rehabilitation of cerebellar ataxia to improve the trunk control and gait stability.  They stated that DMO may be considered a prototype that can be modified in terms of material characteristics, textile layers, elastic components, and diagonal and lateral seams.  These preliminary findings need to be validated by well-designed studies.

Powell et al (2021) noted that complex regional pain syndrome (CRPS) is a relatively rare, but debilitating condition that may occur after limb or peripheral nerve trauma.  Typical symptoms of CRPS include swelling, allodynia, hyperalgesia, and skin temperature changes.  Although a variety of pharmacological and non-pharmacological approaches are commonly used in managing individuals with CRPS, they are frequently ineffective and often associated with side effects and/or additional risks.  Previously, elastomeric orthotic garments have been shown to decrease neuropathic pain, reduce edema, and increase proprioception, but no previous reports have described their use in treating CRPS.  In a case-series study, these researchers described their experiences using a Lycra-based, custom-fabricated DMO as a novel treatment to reduce the symptoms of CRPS and promote function.  A total of 4 patients were included in this study, all of whom had very different causes for their CRPS, including a combat-related gunshot injury resulting in multiple foot fractures with a partial nerve injury, a post-metatarsophalangeal fusion, an L5 radiculopathy, and a case of post-lower leg fasciotomies.  These 4 patients all reported subjective improvement in their pain, function, and exercise tolerance in association with their DMO use.  All 4 demonstrated reduced use of analgesic medications.  The authors stated that the pre- and post-DMO lower extremity functional scale showed clinically significant improvement in the 2 patients for which it was obtained.  Moreover, these researchers stated that although DMOs may represent a promising, safe, and cost-effective adjunct to traditional treatments for CRPS, its scientific basis must still be established.  They stated that future studies should be carried out to examine the effectiveness of DMOs for the treatment of upper and lower limb CRPS in a prospective, controlled fashion.

Robotic Suits

Awad and colleagues (2017) noted that stroke-induced hemi-paretic gait is characteristically slow and metabolically expensive.  Passive assistive devices such as ankle-foot orthoses are often prescribed to increase function and independence after stroke; however, walking remains highly impaired despite-and perhaps because of-their use.  These researchers examined if a soft wearable robot (exosuit) designed to supplement the paretic limb's residual ability to generate both forward propulsion and ground clearance could facilitate more normal walking after stroke.  Exosuits transmit mechanical power generated by actuators to a wearer through the interaction of garment-like, functional textile anchors and cable-based transmissions.  They evaluated the immediate effects of an exosuit actively assisting the paretic limb of individuals in the chronic phase of stroke recovery during treadmill and over-ground walking.  Using controlled, treadmill-based biomechanical investigation, these investigators demonstrated that exosuits could function in synchrony with a wearer's paretic limb to facilitate an immediate 5.33 ± 0.91° increase in the paretic ankle's swing phase dorsiflexion and 11 ± 3 % increase in the paretic limb's generation of forward propulsion (p < 0.05).  These improvements in paretic limb function contributed to a 20 ± 4 % reduction in forward propulsion inter-limb asymmetry and a 10 ± 3 % reduction in the energy cost of walking, which was equivalent to a 32 ± 9 % reduction in the metabolic burden associated with post-stroke walking.  Relatively low assistance (approximately 12 % of biological torques) delivered with a light-weight and non-restrictive exosuit was sufficient to facilitate more normal walking in ambulatory individuals after stroke.  The authors concluded that future work will focus on understanding how exosuit-induced improvements in walking performance may be leveraged to improve mobility after stroke.

Watanabe and associates (2019) noted that spinal cord injury (SCI) causes gait disturbance because of paresis, spasticity, and sensory disturbance of the lower limbs.  There is no effective medical treatment for SCI, and conventional rehabilitation alone is the main approach to helping individuals work toward independent walking.  These researchers evaluated the effect of gait treatment using the Hybrid Assistive Limb (HAL) on acute SCI.  A 61-year old woman and a 62-year old man with incomplete paraplegia participated in this study.  Study participants received gait treatment with HAL 3 to 4 times per week, with a total of 7 to 8 sessions (20 mins), in addition to conventional physical therapy.  The American Spinal Injury Association Impairment Scale, Lower Extremity Motor Score (LEMS), Modified Ashworth Scale (MAS), the Walking Index for Spinal Cord Injury (WISCI II), comfortable gait speed (CGS), stride, cadence, Barthel Index (BI), Functional Independence Measure (FIM), modified Rankin Scale (mRS), joint angles, and adverse effects were assessed prior to HAL treatment and post-HAL treatment.  HAL facilitated intensive gait treatment in people during the acute phase after SCI.  Improvements in LEMS, WISCI II, CGS, stride, cadence, BI, FIM, mRS, and joint angles were observed in both study participants.  Furthermore, decreased spasticity in the gastrocnemius muscle was found in 1 participant as assessed by MAS.  The authors concluded that gait treatment using HAL may be beneficial for paraplegic, non-ambulatory individuals with acute SCI; HAL may be useful for intensive gait treatment without increasing spasticity.

Benik Vest/Trunk Support (Benik Dynamic Trunk Orthosis)

The Benik vest/trunk support (Benik dynamic trunk orthosis) is a 2-piece dynamic body vest that is constructed of 3mm ventilated neoprene and is terry-lined for comfort. Velcro straps on the front half of the vest adhere to the Velcro-sensitive material of the vest back. Velcro straps at shoulders, sides and crotch provide for maximum adjustment. The orthosis provides upper trunk support and proprioceptive input. The vest will provide warmth and added buoyancy during hydrotherapy and other water activities, but is not to be used as a life preserver. 

There is a lack of evidence regarding the effectiveness of the Benik vest/trunk support (Benik dynamic trunk orthosis) for any indication.

Elastomeric Tissue Dynamic Orthosis

Belizon-Bravo et al (2021) stated that dynamic suit orthoses (DSO) are currently used as a complementary treatment method in children with CP (cwCP).  In a systematic review, these investigators examined the effects of interventions with DSO on the altered spatio-temporal gait parameters (STGPs) in cwCP.  They carried out an electronic search in the Web of Science, Scopus, PEDro, Cochrane Library, Medline/PubMed, and CINAHL databases up to July 2021.  These researchers included a total of 12 studies, which showed great heterogeneity in terms of design type, sample size, and intervention performed (2 employed a Therasuit, 3 employed the Adeli Suit, 3 employed TheraTogs, 1 employed elastomeric tissue dynamic orthosis, 1 employed a full-body suit, 1 employed external belt orthosis, and 1 employed dynamic orthosis composed of trousers and T-shirt).  The Cochrane collaboration's tool and the Checklist for Measuring Study Quality were used to evaluate the risk of bias and the methodological quality of the studies.  It was variable according to the Checklist for Measuring Study Quality, and it oscillated between 8 and 23.  The studies of higher methodological quality showed significant post-intervention changes in walking speed (which was the most widely evaluated parameter), cadence, stride length, and step length symmetry.  The authors concluded that although the evidence was limited, the intervention with DSO combined with a program of training/physical therapy appeared to have positive effects on the STGPs in cwCP, with the functional improvements that it entailed.  Despite the immediate effect after 1 session, a number of sessions between 18 and 60 was recommended to obtain optimum results.  Moreover, these researchers stated that future studies should measure all STGPs, and not only the main ones, such as gait speed, in order to draw more accurate conclusions on the functional improvement of gait after the use of this type of intervention.

The authors stated that this review had several drawbacks, such as the restrictions of language (only studies published in English and Spanish) and databases (Web of Science, Scopus, PEDro, Cochrane Library, Medline, and CINAHL).  The main difficulties were observed in the heterogeneity of the included study designs due to the scarce number of articles found and the absence of research with high methodological quality.  From the present review derived the need to continue developing studies of high methodological quality on this topic that examine the effects of the DSO on the STGP already evaluated, in addition to the swing time, support time, and stride width, since these are especially related to the risk of falling in the individual, and the positive results could condition important functional changes.  Finally, future studies are encouraged to compare the effects achieved with different DSO models on the STGP disturbances in cwCP after being used with the same exercise program and intervention dose.  There is no standardized protocol for the use of this type of device, and these drawbacks should be considered when advising parents.  Thus, although suit therapy is not recommended as a stand-alone treatment, it would be important to recognize it as an add-on treatment for some families.  The process of donning a suit may mean they engage in more intensive therapies and active practice, which may produce positive results.  These investigators noted that there is also a need for further research including long-term follow-up of subjects to see if the results obtained are sustained over the years as in other studies on cwCP gait.

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